Hosp Case Manag. 1997 May;5(5):81-3.
New regulations now being considered by the Food and Drug Administration (FDA) could affect the software you use to run your electronic patient record and electronic clinical pathway systems. The standards would impose a federal approval process on all computerized medical record programs and financial systems currently in use at hospitals. The FDA's primary focus is on commercially developed software. Although some worry that the agency will also attempt to regulate software developed in-house by hospitals, it's now likely that such software will be exempted from regulation. Although the agency has not released a final version of the regulatory standards, FDA officials expect action to be taken within the next few months.
美国食品药品监督管理局（FDA）正在审议的新规定可能会影响你用于运行电子病历和电子临床路径系统的软件。这些标准将对医院目前使用的所有计算机化医疗记录程序和财务系统实施联邦审批程序。FDA的主要关注点是商业开发的软件。尽管有些人担心该机构也会试图监管医院内部开发的软件，但现在这类软件很可能会被豁免监管。尽管该机构尚未发布监管标准的最终版本，但FDA官员预计将在未来几个月内采取行动。
